A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Completed · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.

Key facts

Study ID

NCT06411899

Run by

MoonLake Immunotherapeutics AG

People needed

422

Starts

2024-05-15

Expected to finish

2026-05-14

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be at least 18 years of age at the time of signing the informed consent.
• Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
• Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
• Participants who have a total AN count of ≥5.
• Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

You may not qualify if…

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
• Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
• Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
• Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
• Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.

Where it is running

• Clinical Site — Northridge, California, United States
• Clinical Site — Sacramento, California, United States
• Clinical Site — San Diego, California, United States
• Clinical Site — Coral Gables, Florida, United States
• Clinical Site — Coral Springs, Florida, United States
• Clinical Site — Hollywood, Florida, United States
• Clinical Site — Margate, Florida, United States
• Clinical Site — Miami, Florida, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Macon, Georgia, United States
• Clinical Site — Sandy Springs, Georgia, United States
• Clinical Site — West Dundee, Illinois, United States
• Clinical Site — Columbus, Indiana, United States
• Clinical Site — New Albany, Indiana, United States
• Clinical Site — Louisville, Kentucky, United States
• Clinical Site — Metairie, Louisiana, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Dearborn, Michigan, United States
• Clinical Site — Warren, Michigan, United States
• Clinical Site — Las Vegas, Nevada, United States
• Clinical Site — New York, New York, United States
• Clinical Site — The Bronx, New York, United States
• Clinical Site — Boardman, Ohio, United States
• Clinical Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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